Pancreatic adenocarcinoma still represents one of the "hot-topics" worldwide. Endoscopic ultrasonography was a breakthrough, bringing us closer to personalized treatment by getting histopathological samples through fine-needle-aspiration or fine-needle-biopsy. These samples can be analyzed and offer the possibility to detect a micro-RNA profile. Micro-RNAs are small non-coding RNA molecules that interfere in genic expression. Many studies focused on seric microRNA profile, though there are many implications in tissue micro-RNA profile, thus overexpression or under expression of these molecules might help us not only understand different cellular processes, but also interfere in personalized medicine in the future. The investigators propose a prospective, multicenter, randomized, cohort study on 60 patients with solid pancreatic masses to evaluate tissue microRNA profile obtained by EUS-FNA. The primary hypothesis is to correlate the microRNA tissular expression in pancreatic adenocarcinoma with tumor aggressive behavior, survival and response to treatment. The samples will be obtained from the participants during endoscopic ultrasonography, through fine needle aspiration, after consent was given to be a part of the study prior to the intervention. The probe will be preserved in a special recipient that stabilizes RNA and inhibits RNA-lazes, thus preventing RNA degradation by endogenous ribonucleases. The analysis of miRNA profile will be made using qRT-PCR array method, by miScript II RT Kit, miScript SYBR Green PCR Kit și miScript miRNA PCR Array Human Cancer Pathway Finder (MIHS-102Z) (Qiagen, GmbH). Thus a kit containing a number of 84 miRNAs will be analysed in every participant.
Study Type
OBSERVATIONAL
Enrollment
60
Patients with solid pancreatic masses fulfilling the inclusion and exclusion criteria will receive EUS FNA (endoscopic ultrasound fine needle aspiration).
"Carol Davila" University Central Emergency Hospital
Bucharest, Sector 1, Romania
RECRUITING"Prof Dr Agrippa Ionescu" Emergency Hospital
Bucharest, Sector 1, Romania
RECRUITINGClinical Emergency Hospital Bucharest
Bucharest, Sector 1, Romania
RECRUITINGFundeni Clinical Institute
Bucharest, Sector 2, Romania
COMPLETED"Victor Babes" National Pathology Institute
Bucharest, Sector, Romania
RECRUITINGMean change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status, weight and survival in patients with pancreatic adenocarcinoma according to tissue microRNA expression
Eastern Cooperative Oncology Group (ECOG) performance status, weight and survival will be assessed though different consultations (in person or by telemedicine): at first presentation, at 1 month, at 3 months, at 6 months and at one year.
Time frame: through study completion, an average of 2 and a half years
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